[Federal Register Volume 90, Number 114 (Monday, June 16, 2025)]
[Rules and Regulations]
[Pages 25123-25134]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-10797]
========================================================================
Rules and Regulations
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by the Superintendent of Documents.
========================================================================
Federal Register / Vol. 90, No. 114 / Monday, June 16, 2025 / Rules
and Regulations
[[Page 25123]]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
7 CFR Parts 330, 340, and 372
[Docket No. APHIS-2018-0034]
RIN 0579-AE47
Movement of Certain Genetically Engineered Organisms
AGENCY: Animal and Plant Health Inspection Service, Department of
Agriculture (USDA).
ACTION: Final rule; technical amendments.
-----------------------------------------------------------------------
SUMMARY: On December 2, 2024, a Federal court vacated the Animal and
Plant Health Inspection Service (APHIS) final rule issued on May 18,
2020 (the May 2020 final rule) that revised APHIS' regulations
governing the movement of certain genetically modified organisms and
was issued under the authority of the Plant Protection Act. APHIS is
therefore amending the CFR to conform the CFR to the Federal Court's
vacatur of that rule. The Court's vacatur was effective December 2,
2024, and had the legal effect of vacating the May 2020 final rule in
its entirety and restoring the legal effect of the pre-May 2020
regulations. These technical conforming amendments revise the CFR to
reflect the court's vacatur of the May 2020 final rule.
DATES: This rule is effective June 16, 2025. The Federal Court's
vacatur of the rule amendments published on May 18, 2020, at 85 FR
29790, was applicable as of December 2, 2024.
FOR FURTHER INFORMATION CONTACT: Alan Pearson, Biotechnology Regulatory
Services, APHIS, USDA, 4700 River Road, Unit 78, Riverdale, MD 20737-
1236; (301) 851-3944; email: [email protected].
SUPPLEMENTARY INFORMATION: The Animal and Plant Health Inspection
Service is adopting technical amendments to the following regulations:
7 CFR 330.200(b) and (d), 7 CFR part 340, and 7 CFR 372.5(b)(7) and
(c)(3) and (4).
Background
The regulations at 7 CFR part 340 govern the introduction
(importation, interstate movement, or release into the environment) of
certain genetically engineered (GE) organisms. APHIS first issued these
regulations in 1987 under the authority of the Federal Plant Pest Act
of 1957 and the Plant Quarantine Act of 1912, two acts that were later
subsumed into the Plant Protection Act (PPA, 7 U.S.C. 7701 et seq.) in
2000, along with other provisions. Since 1987 and prior to 2020, APHIS
amended the regulations six times, in 1988, 1990, 1993, 1994, 1997, and
2005, to institute exemptions from the requirement for permits to
conduct activities for certain microorganisms and Arabidopsis, to
institute a notification process and petition procedure, and to exclude
plants engineered to produce industrial compounds from the notification
process. On May 18, 2020, APHIS issued a final rule revising 7 CFR part
340 in its entirety (85 FR 29790-29838, Docket No. APHIS-2018-0034,
referred to below as the May 2020 final rule). The rule also made
harmonizing changes to 7 CFR part 330, which governs the movement
(importation, interstate movement, and environmental release) of plant
pests, and 7 CFR part 372, which contains APHIS' National Environmental
Policy Act (43 U.S.C. 4321 et seq.) implementing regulations.
Litigation
On July 26, 2021, the National Family Farm Coalition (``NFFC''),
Center for Food Safety, and Pesticide Action Network North America
Diversity (collectively, Plaintiffs) on behalf of themselves and their
members filed a complaint in the United States District Court for the
Northern District of California, challenging the May 2020 final rule.
The complaint alleged that the May 2020 final rule violated the
Administrative Procedure Act (5 U.S.C. 551-559, APA), among other
statutes. The parties subsequently completed briefings on cross motions
for summary judgment.
Vacatur
On December 2, 2024, the United States District Court of the
Northern District of California issued its decision. The Court held
that APHIS had violated the APA in issuing the May 2020 final rule. In
its order, the Court vacated the May 2020 final rule in its entirety,
including revisions to 7 CFR parts 330, 340, and 372. (The vacatur is
prospective, which means that Agency actions taken under the May 2020
final rule, such as Regulatory Status Review responses, Confirmation
Request responses, and active permits that USDA issued prior to
December 2, 2024, remain valid.) As a result, pursuant to the Court's
order, the pre-May 2020 regulations again became operative and took
legal effect on December 2, 2024. APHIS provided notice to the
regulated parties of this development on December 4, 2024. See APHIS
Stakeholder Registry Email of December 4, 2024. The Court's decision is
now final. Accordingly, this technical amendment conforms the CFR with
the Court's vacatur by replacing the regulations in the now-vacated May
2020 final rule with the text of the regulations that were in effect
prior to the May 2020 final rule, and which are now operative and in
legal effect.
Good Cause
The APA generally requires an agency to publish notice of a
proposed rulemaking in Federal Register and provide an opportunity for
public comment. This requirement does not apply, however, if the agency
``for good cause finds . . . that notice and public procedure are
impracticable, unnecessary, or contrary to the public interest.'' (5
U.S.C. 553(b)(B)) The technical amendments we are making to the CFR
merely reflect the Court's vacatur of the May 2020 final rule and
neither impose nor relieve regulatory requirements on any person.
Rather, those regulatory requirements are imposed because of the
Court's vacatur of the May 2020 final rule and the return to the pre-
May 2020 regulations that occurred by operation of law. See Paulsen v.
Daniels, 413 F.3d 999, 1008 (9th Cir. 2005) (``The effect of
invalidating an agency rule is to reinstate the rule previously in
force.''); Nat'l Fam. Farm Coal. v. Vilsack, 758 F. Supp. 3d 1060, 1081
(N.D. Cal. 2024) (``this . . . vacatur suffices to return the industry
and GE-crop regulation to the status quo ante''). Insofar as public
comment has no material bearing on the
[[Page 25124]]
reality of the vacatur, APHIS finds good cause that notice and public
comment are unnecessary.
For similar reasons, although the APA generally requires
publication of a rule at least 30 days before its effective date, APHIS
finds there to be good cause for the amendments to take effect upon
publication of this document in the Federal Register.
List of Subjects
7 CFR Part 330
Customs duties and inspection, Plant diseases and pests,
Quarantine, Reporting and recordkeeping requirements, Transportation.
7 CFR Part 340
Administrative practice and procedure, Packaging and containers,
Plant diseases and pests, Reporting and recordkeeping requirements,
Transportation.
7 CFR Part 372
Environmental impact statements.
Accordingly, we are amending 7 CFR parts 330, 340, and 372 as
follows:
PART 330--FEDERAL PLANT PEST REGULATIONS; GENERAL; PLANT PESTS,
BIOLOGICAL CONTROL ORGANISMS, AND ASSOCIATED ARTICLES; GARBAGE
0
1. The authority citation for part 330 continues to read as follows:
Authority: 7 U.S.C. 1633, 7701-7772, 7781-7786, and 8301-8317;
21 U.S.C. 136 and 136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.3.
0
2. In Sec. 330.200, paragraphs (b) and (d) are revised to read as
follows:
Sec. 330.200 Scope and general restrictions.
* * * * *
(b) Plant pests regulated by this subpart. For the purposes of this
subpart, APHIS will consider an organism to be a plant pest if the
organism directly or indirectly injures, causes damage to, or causes
disease in a plant or plant product, or if the organism is an unknown
risk to plants or plant products, but is similar to an organism known
to directly or indirectly injure, cause damage to, or cause disease in
a plant or plant product.
* * * * *
(d) Biological control organisms not regulated by this subpart.
Paragraph (c) of this section notwithstanding, biological control
organism-containing products that are currently under an EPA
experimental use permit, a Federal Insecticide Fungicide and
Rodenticide Act (FIFRA) section 18 emergency exemption, or that are
currently registered with EPA as a microbial pesticide product, are not
regulated under this subpart. Additionally, biological control
organisms that are pesticides that are not registered with EPA, but are
being transferred, sold, or distributed in accordance with EPA's
regulations in 40 CFR 152.30, are not regulated under this subpart for
their interstate movement or importation. However, an importer desiring
to import a shipment of biological control organisms subject to FIFRA
must submit to the EPA Administrator a Notice of Arrival of Pesticides
and Devices as required by CBP regulations at 19 CFR 12.112. The
Administrator will provide notification to the importer indicating the
disposition to be made of shipment upon its entry into the customs
territory of the United States.
0
3. Part 340 is revised to read as follows:
PART 340--INTRODUCTION OF ORGANISMS AND PRODUCTS ALTERED OR
PRODUCED THROUGH GENETIC ENGINEERING WHICH ARE PLANT PESTS OR WHICH
THERE IS REASON TO BELIEVE ARE PLANT PESTS
Sec.
340.0 Restrictions on the introduction of regulated articles.
340.1 Definitions.
340.2 Groups of organisms which are or contain plant pests and
exemptions.
340.3 Notification for the introduction of certain regulated
articles.
340.4 Permits for the introduction of a regulated article.
340.5 Petition to amend the list of organisms.
340.6 Petition for determination of nonregulated status.
340.7 Marking and identity.
340.8 Container requirements for the movement of regulated articles.
340.9 Costs and charges.
Authority: 7 U.S.C. 7701-7772 and 7781-7786; 31 U.S.C. 9701; 7
CFR 2.22, 2.80, and 371.3.
Sec. 340.0 Restrictions on the introduction of regulated articles.
(a) No person shall introduce any regulated article unless the
Administrator is:
(1) Notified of the introduction in accordance with Sec. 340.3, or
such introduction is authorized in accordance with Sec. 340.4, or such
introduction is conditionally exempt from permit requirements under
Sec. 340.2(b); and
(2) Such introduction is in conformity with all other applicable
restrictions in this part.\1\
---------------------------------------------------------------------------
\1\ Part 340 regulates, among other things, the introduction of
organisms and products altered or produced through genetic
engineering that are plant pests or are believed to be plant pests.
The introduction into the United States of such articles may also be
subject to other regulations promulgated under the Plant Protection
Act (7 U.S.C. 7701-7772) and found in 7 CFR part 319, 330, and 360.
For example, under regulations promulgated in ``Subpart H--Plants
for Planting'' (7 CFR 319.37-5 of this chapter), a permit is
required for the importation of certain classes of plants for
planting whether such plants are genetically engineered or not.
Accordingly, individuals should refer to those regulations before
importing any plants for planting.
---------------------------------------------------------------------------
(b) Any regulated article introduced not in compliance with the
requirements of this part shall be subject to the immediate application
of such remedial measures or safeguards as an inspector determines
necessary to prevent the introduction of such plant pests.\2\
---------------------------------------------------------------------------
\2\ An inspector may hold, seize, quarantine, treat, apply other
remedial measures to, destroy, or otherwise dispose of plants, plant
pests, or other articles in accordance with sections 411, 412, 421,
and 434 of the Plant Protection Act (7 U.S.C. 7711, 7712, 7731, and
7754).
---------------------------------------------------------------------------
Sec. 340.1 Definitions.
Terms used in the singular form in this part shall be construed as
the plural, and vice versa, as the case may demand. The following terms
shall be construed, respectively, to mean:
Administrator. The Administrator of the Animal and Plant Health
Inspection Service (APHIS) or any other employee of APHIS to whom
authority has been or may be delegated to act in the Administrator's
stead.
Animal and Plant Health Inspection Service (APHIS). An agency of
the United States Department of Agriculture.
Antecedent organism. An organism that has already been the subject
of a determination of nonregulated status by APHIS under Sec. 340.6,
and that is used as a reference for comparison to the regulated article
under consideration under these regulations.
Courtesy permit. A written permit issued by the Administrator, in
accordance with Sec. 340.4(h).
Donor organism. The organism from which genetic material is
obtained for transfer to the recipient organism.
Environment. All the land, air, and water; and all living organisms
in association with land, air and water.
Expression vector. A cloning vector designed so that a coding
sequence inserted at a particular site will be transcribed and
translated into protein.
Genetic engineering. The genetic modification of organisms by
recombinant DNA techniques.
[[Page 25125]]
Inspector. Any employee of the Animal and Plant Health Inspection
Service, U.S. Department of Agriculture, or other person, authorized by
the Administrator, in accordance with law to enforce the provisions of
this part.
Interstate. From any State into or through any other State.
Introduce or introduction. To move into or through the United
States, to release into the environment, to move interstate, or any
attempt thereat.
Move (moving, movement). To ship, offer for shipment, offer for
entry, import, receive for transportation, carry, or otherwise
transport or move, or allow to be moved into, through, or within the
United States.
Organism. Any active, infective, or dormant stage or life form of
an entity characterized as living, including vertebrate and
invertebrate animals, plants, bacteria, fungi, mycoplasmas, mycoplasma-
like organisms, as well as entities such as viroids, viruses, or any
entity characterized as living, related to the foregoing.
Permit. A written permit issued by the Administrator, for the
introduction of a regulated article under conditions determined by the
Administrator, not to present a risk of plant pest introduction.
Person. Any individual, partnership, corporation, company, society,
association, or other organized group.
Plant. Any living stage or form of any member of the plant kingdom
\3\ including, but not limited to, eukaryotic algae, mosses, club
mosses, ferns, angiosperms, gymnosperms, and lichens (which contain
algae) including any parts (e.g., pollen, seeds, cells, tubers, stems)
thereof, and any cellular components (e.g., plasmids, ribosomes, etc.)
thereof.
---------------------------------------------------------------------------
\3\ The taxonomic scheme for the plant kingdom is that found in
Synopsis and Classification of Living Organisms by S.P. Parker,
McGraw Hill (1984).
---------------------------------------------------------------------------
Plant pest. Any living stage (including active and dormant forms)
of insects, mites, nematodes, slugs, snails, protozoa, or other
invertebrate animals, bacteria, fungi, other parasitic plants or
reproductive parts thereof; viruses; or any organisms similar to or
allied with any of the foregoing; or any infectious agents or
substances, which can directly or indirectly injure or cause disease or
damage in or to any plants or parts thereof, or any processed,
manufactured, or other products of plants.
Product. Anything made by or from, or derived from an organism,
living or dead.
Recipient organism. The organism which receives genetic material
from a donor organism.
Regulated article. Any organism which has been altered or produced
through genetic engineering, if the donor organism, recipient organism,
or vector or vector agent belongs to any genera or taxa designated in
Sec. 340.2 and meets the definition of plant pest, or is an
unclassified organism and/or an organism whose classification is
unknown, or any product which contains such an organism, or any other
organism or product altered or produced through genetic engineering
which the Administrator, determines is a plant pest or has reason to
believe is a plant pest. Excluded are recipient microorganisms which
are not plant pests and which have resulted from the addition of
genetic material from a donor organism where the material is well
characterized and contains only non-coding regulatory regions.
Release into the environment. The use of a regulated article
outside the constraints of physical confinement that are found in a
laboratory, contained greenhouse, or a fermenter or other contained
structure.
Responsible person. The person who has control and will maintain
control over the introduction of the regulated article and assure that
all conditions contained in the permit and requirements in this part
are complied with. A responsible person shall be a resident of the
United States or designate an agent who is a resident of the United
States.
Secretary. The Secretary of Agriculture, or any other officer or
employee of the Department of Agriculture to whom authority to act in
his/her stead has been or may hereafter be delegated.
Stably integrated. The cloned genetic material is contiguous with
elements of the recipient genome and is replicated exclusively by
mechanisms used by recipient genomic DNA.
State. Any State, the District of Columbia, American Samoa, Guam,
Northern Mariana Islands, Puerto Rico, the Virgin Islands of the United
States, and any other Territories or Districts of the United States.
State regulatory official. State official with responsibilities for
plant health, or any other duly designated State official, in the State
where the introduction is to take place.
United States. All of the States.
Vector or vector agent. Organisms or objects used to transfer
genetic material from the donor organism to the recipient organism.
Well-characterized and contains only non-coding regulatory regions
(e.g., operators, promoters, origins of replication, terminators, and
ribosome binding regions). The genetic material added to a
microorganism in which the following can be documented about such
genetic material: (a) The exact nucleotide base sequence of the
regulatory region and any inserted flanking nucleotides; (b) The
regulatory region and any inserted flanking nucleotides do not code for
protein or peptide; and (c) The regulatory region solely controls the
activity of other sequences that code for protein or peptide molecules
or act as recognition sites for the initiation of nucleic acid or
protein synthesis.
Sec. 340.2 Groups of organisms which are or contain plant pests and
exemptions.
(a) Groups of organisms which are or contain plant pests. The
organisms that are or contain plant pests are included in the taxa or
group of organisms contained in the following list. Within any
taxonomic series included on the list, the lowest unit of
classification actually listed is the taxon or group which may contain
organisms which are regulated. Organisms belonging to all lower taxa
contained within the group listed are included as organisms that may be
or may contain plant pests, and are regulated if they meet the
definition of plant pest in Sec. 340.1.\4\
---------------------------------------------------------------------------
\4\ Any organism belonging to any taxa contained within any
listed genera or taxa is only considered to be a plant pest if the
organism ``can directly or indirectly injure, or cause disease, or
damage in any plants or parts thereof, or any processed,
manufactured, or other products of plants.'' Thus a particular
unlisted species within a listed genus would be deemed a plant pest
for purposes of Sec. 340.2, if the scientific literature refers to
the organism as a cause of direct or indirect injury, disease, or
damage to any plants, plant parts or products of plants. (If there
is any question concerning the plant pest status of an organism
belonging to any listed genera or taxa, the person proposing to
introduce the organism in question should consult with APHIS to
determine if the organism is subject to regulation.)
Note: Any genetically engineered organism composed of DNA or RNA
sequences, organelles, plasmids, parts, copies, and/or analogs, of
or from any of the groups of organisms listed below shall be deemed
a regulated article if it also meets the definition of plant pest in
---------------------------------------------------------------------------
Sec. 340.1.
GROUP
VIROIDS
Superkingdom Prokaryotae
Kingdom Virus
All members of groups containing plant viruses, and all other plant and
insect viruses
Kingdom Monera
DIVISION BACTERIA
Family Pseudomonadaceae
Genus Pseudomonas
[[Page 25126]]
Genus Xanthomonas
Family Rhizobiaceae
Genus Rhizobium
Genus Bradyrhizobium
Genus Agrobacterium
Genus Phyllobacterium
Family Enterobacteriaceae
Genus Erwinia
Family Streptomycetaceae
Genus Streptomyces
Family Actinomycetacease
Genus Actinomyces
Coryneform Group
Genus Clavibacter
Genus Arthrobacter
Genus Curtobacterium
Genus Corynebacteria
Gram-negative phloem-limited bacteria associated with plant diseases
Gram-negative xylem-limited bacteria associated with plant diseases
And all other bacteria associated with plant or insect diseases
Rickettsiaceae
Rickettgial-like organisms associated with insect diseases
Class Mollicutes
Order Mycoplasmatales
Family Spiroplasmataceae
Genus Spiroplasma
Mycoplasma-like organisms associated with plant diseases
Mycoplasma-like organisms associated with insect diseases
Superkingdom Eukaryotae
Kingdom Plantae
Subkingdom Thallobionta
DIVISION CHLOROPHYTA
Genus Cephaleuros
Genus Rhodochytrium
Genus Phyllosiphon
DIVISION MYXOMYCOTA
Class Plasmodiophoromycetes
DIVISION EUMYCOTA
Class Chytridiomycetes
Order Chytridiales
Class Oomycetes
Order Lagenidiales
Family Lagenidiaceae
Family Olpidiopsidaceae
Order Peronosporales
Family Albuginaceae
Family Peronosporaceae
Family Pythiaceae
Order Saprolegniales
Family Saprolegniaceae
Family Leptolegniellaceae
Class Zygomycetes
Order Mucorales
Family Choanephoraceae
Family Mucoraceae
Family Entomophthoraceae
Class Hemiascomycetes
Family Protomycetaceae
Family Taphrinaceae
Class Loculoascomycetes
Order Myriangiales
Family Elsinoeaceae
Family Myriangiaceae
Order Asterinales
Order Dothideales
Order Chaetothyriales
Order Hysteriales
Family Parmulariaceae
Family Phillipsiellaceae
Family Hysteriaceae
Order Pleosporales
Order Melanommatales
Class Plectomycetes
Order Eurotiales
Family Ophiostomataceae
Order Ascophaerales
Class Pyrenomycetes
Order Erysiphales
Order Meliolales
Order Xylariales
Order Diaporthales
Order Hypocreales
Order Clavicipitales
Class Discomycetes
Order Phacidiales
Order Helotiales
Family Ascocorticiceae
Family Hemiphacidiaceae
Family Dermataceae
Family Sclerotiniaceae
Order Cytarriales
Order Medeolariales
Order Pezziales
Family Sarcosomataceae
Family Sarcoscyphaceae
Class Teliomycetes
Class Phragmobasidiomycetes
Family Auriculariaceae
Family Ceratobasidiaceae
Class Hymenomycetes
Order Exobasidiales
Order Agaricales
Family Corticiaceae
Family Hymenochaetaceae
Family Echinodontiaceae
Family Fistulinaceae
Family Clavariaceae
Family Polyporaceae
Family Tricholomataceae
Class Hyphomycetes
Class Coelomycetes
And all other fungi associated with plant or insect diseases
Subkingdom Embryobionta
Note: Organisms listed in the Code of Federal Regulations as
noxious weeds are regulated under the Federal Noxious Weed Act.
DIVISION MAGNOLIOPHYTA
Family Balanophoraceae--parasitic species
Family Cuscutaceae--parasitic species
Family Hydnoraceae--parasitic species
Family Krameriaceae--parasitic species
Family Lauraceae--parasitic species
Genus Cassytha
Family Lennoaceae--parasitic species
Family Loranthaceae--parasitic species
Family Myzodendraceae--parasitic species
Family Olacaceae--parasitic species
Family Orobanchaceae--parasitic species
Family Rafflesiaceae--parasitic species
Family Santalaceae--parasitic species
Family Scrophulariaceae--parasitic species
Genus Alectra
Genus Bartsia
Genus Buchnera
Genus Buttonia
Genus Castilleja
Genus Centranthera
Genus Cordylanthus
Genus Dasistoma
Genus Euphrasia
Genus Gerardia
Genus Harveya
Genus Hyobanche
Genus Lathraea
Genus Melampyrum
Genus Melasma
Genus Orthantha
Genus Orthocarpus
Genus Pedicularis
Genus Rhamphicarpa
Genus Rhinanthus
Genus Schwalbea
Genus Seymeria
Genus Siphonostegia
Genus Sopubia
Genus Striga
Genus Tozzia
Family Viscaceae--parasitic species
Kingdom Animalia
Subkingdom Protozoa
Genus Phytomonas
And all Protozoa associated with insect diseases
Subkingdom Eumetazoa
PHYLUM NEMATA
Class Secernentea
Order Tylenchida
Family Anguinidae
Family Belonolaimidae
Family Caloosiidae
Family Criconematidae
Family Dolichodoridae
Family Fergusobiidae
Family Hemicycliophoridae
[[Page 25127]]
Family Heteroderidae
Family Hoplolaimidae
Family Meloidogynidae
Family Nacobbidae
Family Neotylenchidae
Family Nothotylenchidae
Family Paratylenchidae
Family Pratylenchidae
Family Tylenchidae
Family Tylenchulidae
Order Aphelenchida
Family Aphelenchoididae
Class Adenophorea
Order Dorylaimida
Family Longidoridae
Family Trichodoridae
PHYLUM MOLLUSCA
Class Gastropoda
Subclass Pulmonata
Order Basommatophora
Superfamily Planorbacea
Order Stylommatophora
Subfamily Strophocheilacea
Family Succineidae
Superfamily Achatinacae
Superfamily Arionacae
Superfamily Limacacea
Superfamily Helicacea
Order Systellommatophora
Superfamily Veronicellacea
PHYLUM ARTHROPODA
Class Arachnida
Order Parasitiformes
Suborder Mesostigmata
Superfamily Ascoidea
Superfamily Dermanyssoidea
Order Acariformes
Suborder Prostigmata
Superfamily Eriophyoidea
Superfamily Tetranychoidea
Superfamily Eupodoidea
Superfamily Tydeoidea
Superfamily Erythraenoidea
Superfamily Trombidioidea
Superfamily Hydryphantoidea
Superfamily Tarsonemoidea
Superfamily Pyemotoidea
Suborder Astigmata
Superfamily Hemisarcoptoidea
Superfamily Acaroidea
Class Diplopoda
Order Polydesmida
Class Insecta
Order Collembola
Family Sminthoridae
Order Isoptera
Order Thysanoptera
Order Orthoptera
Family Acrididae
Family Gryllidae
Family Gryllacrididae
Family Gryllotalpidae
Family Phasmatidae
Family Ronaleidae
Family Tettigoniidae
Family Tetrigidae
Order Hemiptera
Family Thaumastocoridae
Family Aradidae
Superfamily Piesmatoidea
Superfamily Lygaeoidea
Superfamily Idiostoloidea
Superfamily Coreoidea
Superfamily Pentatomoidea
Superfamily Pyrrhocoroidea
Superfamily Tingoidea
Superfamily Miroidea
Order Homoptera
Order Coleoptera
Family Anobiidae
Family Apionidae
Family Anthribidae
Family Bostrichidae
Family Brentidae
Family Bruchidae
Family Buprestidae
Family Byturidae
Family Cantharidae
Family Carabidae
Family Cerambycidae
Family Chrysomelidae
Family Coccinellidae
Subfamily Epilachninae
Family Curculionidae
Family Dermestidae
Family Elateridae
Family Hydrophilidae
Genus Helophorus
Family Lyctidae
Family Meloidae
Family Mordellidae
Family Platypodidae
Family Scarabaeidae
Subfamily Melolonthinae
Subfamily Rutelinae
Subfamily Cetoniinae
Subfamily Dynastinae
Family Scolytidae
Family Selbytidae
Family Tenebrionidae
Order Lepidoptera
Order Diptera
Family Agromyzidae
Family Anthomyiidae
Family Cecidomyiidae
Family Chloropidae
Family Ephydridae
Family Lonchaeidae
Family Muscidae
Genus Atherigona
Family Otitidae
Genus Euxeta
Family Syrphidae
Family Tephritidae
Family Tipulidae
Order Hymenoptera
Family Apidae
Family Caphidae
Family Chalcidae
Family Cynipidae
Family Eurytomidae
Family Formicidae
Family Psilidae
Family Siricidae
Family Tenthredinidae
Family Torymidae
Family Xylocopidae
Unclassified organisms and/or organisms whose classification is
unknown.
(b) Exemptions. (1) A limited permit for interstate movement shall
not be required for genetic material from any plant pest contained in
Escherichia coli genotype K-12 (strain K-12 and its derivatives),
sterile strains of Saccharomyces cerevisiae, or asporogenic strains of
Bacillus subtilis, provided that all the following conditions are met:
(i) The microorganisms are shipped in a container that meets the
requirements of Sec. 340.8(b)(3);
(ii) The cloned genetic material is maintained on a nonconjugation
proficient plasmid and the host does not contain other conjugation
proficient plasmids or generalized transducing phages;
(iii) The cloned material does not include the complete infectious
genome of a known plant pest;
(iv) The cloned genes are not carried on an expression vector if
the cloned genes code for:
(A) A toxin to plants or plant products, or a toxin to organisms
beneficial to plants; or
(B) Other factors directly involved in eliciting plant disease
(i.e., cell wall degrading enzymes); or
(C) Substances acting as, or inhibitory to, plant growth
regulators.
(2) A limited permit for interstate movement is not required for
genetic material from any plant pest contained in the genome of the
plant Arabiodopsis thaliana, provided that all of the following
conditions are met:
(i) The plants or plant materials are shipped in a container that
meets the requirements of Sec. 340.8(b)(1), (2), and (3);
(ii) The cloned genetic material is stably integrated into the
plant genome;
(iii) The cloned material does not include the complete infectious
genome of a known plant pest.
Sec. 340.3 Notification for the introduction of certain regulated
articles.\5\
---------------------------------------------------------------------------
\5\ APHIS may issue guidelines regarding scientific procedures,
practices, or protocols which it has found acceptable in making
various determinations under the regulations. A person may follow an
APHIS guideline or follow different procedures, practices, or
protocols. When different procedures, practices, or protocols are
followed, a person may, but is not required to, discuss the matter
in advance with APHIS to help ensure that the procedures, practices,
or protocols to be followed will be acceptable to APHIS.
---------------------------------------------------------------------------
(a) General. Certain regulated articles may be introduced without a
permit,
[[Page 25128]]
provided that the introduction is in compliance with the requirements
of this section. Any other introduction of regulated articles require a
permit under Sec. 340.4, with the exception of introductions that are
conditionally exempt from permit requirements under Sec. 340.2(b) of
this part.
(b) Regulated articles eligible for introduction under the
notification procedure. Regulated articles which meet all of the
following six requirements and the performance standards set forth in
paragraph (c) of this section are eligible for introduction under the
notification procedure.
(1) The regulated article is any plant species that is not listed
as a noxious weed in regulations at 7 CFR part 360 under the Plant
Protection Act (7 U.S.C. 7712), and, when being considered for release
into the environment, the regulated article is not considered by the
Administrator to be a weed in the area of release into the environment.
(2) The introduced genetic material is ``stably integrated'' in the
plant genome, as defined in Sec. 340.1.
(3) The function of the introduced genetic material is known and
its expression in the regulated article does not result in plant
disease.
(4) The introduced genetic material does not:
(i) Cause the production of an infectious entity, or
(ii) Encode substances that are known or likely to be toxic to
nontarget organisms known or likely to feed or live on the plant
species, or
(iii) Encode products intended for pharmaceutical or industrial
use.
(5) To ensure that the introduced genetic sequences do not pose a
significant risk of the creation of any new plant virus, plant virus-
derived sequences must be:
(i) Noncoding regulatory sequences of known function, or
(ii) Sense or antisense genetic constructs derived from viral genes
from plant viruses that are prevalent and endemic in the area where the
introduction will occur and that infect plants of the same host
species, and that do not encode a functional noncapsid gene product
responsible for cell-to-cell movement of the virus.
(6) The plant has not been modified to contain the following
genetic material from animal or human pathogens:
(i) Any nucleic acid sequence derived from an animal or human
virus, or
(ii) Coding sequences whose products are known or likely causal
agents of disease in animals or humans.
(c) Performance standards for introductions under the notification
procedure. The following performance standards must be met for any
introductions under the notification procedure.
(1) If the plants or plant materials are shipped, they must be
shipped in such a way that the viable plant material is unlikely to be
disseminated while in transit and must be maintained at the destination
facility in such a way that there is no release into the environment.
(2) When the introduction is an environmental release, the
regulated article must be planted in such a way that they are not
inadvertently mixed with non-regulated plant materials of any species
which are not part of the environmental release.
(3) The plants and plant parts must be maintained in such a way
that the identity of all material is known while it is in use, and the
plant parts must be contained or devitalized when no longer in use.
(4) There must be no viable vector agent associated with the
regulated article.
(5) The field trial must be conducted such that:
(i) The regulated article will not persist in the environment, and
(ii) No offspring can be produced that could persist in the
environment.
(6) Upon termination of the field test:
(i) No viable material shall remain which is likely to volunteer in
subsequent seasons, or
(ii) Volunteers shall be managed to prevent persistence in the
environment.
(d) Procedural requirements for notifying APHIS. The following
procedures shall be followed for any introductions under the
notification procedure:
(1) Notification should be directed to the Animal and Plant Health
Inspection Service, Plant Protection and Quarantine, Biotechnology and
Scientific Services, Biotechnology Permits, 4700 River Road, Unit 147,
Riverdale, Maryland 20737-1237.
(2) The notification shall include the following:
(i) Name, title, address, telephone number, and signature of the
responsible person;
(ii) Information necessary to identify the regulated article(s),
including:
(A) The scientific, common, or trade names, and phenotype of
regulated article,
(B) The designations for the genetic loci, the encoded proteins or
functions, and donor organisms for all genes from which introduced
genetic material was derived, and
(C) The method by which the recipient was transformed;
(iii) The names and locations of the origination and destination
facilities for movement or the field site location for the
environmental release; and the size of the introduction,
(iv) The date and, in the case of environmental release, the
expected duration of the introduction (release); and
(v) A statement that certifies that introduction of the regulated
article will be in accordance with the provisions of this section.
(3) Notification must be submitted to APHIS:
(i) At least 10 days prior to the day of introduction, if the
introduction is interstate movement.
(ii) At least 30 days prior to the day of introduction, if the
introduction is an importation.
(iii) At least 30 days prior to the day of introduction, if the
introduction is an environmental release.
(4) Field test reports must be submitted to APHIS within 6 months
after termination of the field test. Field test reports shall include
the APHIS reference number, methods of observation, resulting data, and
analysis regarding all deleterious effects on plants, nontarget
organisms, or the environment.
(5) The Administrator, shall be notified of any unusual occurrence
within the time periods and in the manner specified in Sec.
340.4(f)(10).
(6) Access shall be allowed for APHIS and State regulatory
officials to inspect facilities and/or the field test site and any
records necessary to evaluate compliance with the provisions of
paragraphs (b) and (c) of this section.
(e) Administrative action in response to notification. (1) APHIS
will provide copies of all notifications to appropriate State
regulatory official(s) for review within 5 business days of receipt.
Comments to APHIS from appropriate State regulatory officials in
response to notifications for interstate movement of regulated articles
will not be required by APHIS prior to acknowledgment, although States
may provide their reviews to APHIS at their discretion.
(2) The Administrator, will provide acknowledgement within 10 days
of receipt that the interstate movement is appropriate under
notification.
(3) The Administrator, will provide acknowledgement within 30 days
of receipt that the importation is appropriate under notification.
(4) APHIS will provide acknowledgment within 30 days of
[[Page 25129]]
receipt that the environmental release is appropriate under
notification. Such acknowledgment will apply to field testing for 1
year from the date of introduction, and may be renewed annually by
submission of an additional notification to APHIS.
(5) A person denied permission for introduction of a regulated
article under notification may apply for a permit for introduction of
that regulated article without prejudice.
Sec. 340.4 Permits for the introduction of a regulated
article.6
---------------------------------------------------------------------------
\6\ See footnote 5 in Sec. 340.3.
---------------------------------------------------------------------------
(a) Application for permit. Two copies of a written application for
a permit to introduce a regulated article, which may be obtained from
APHIS, shall be submitted by the responsible person to the Animal and
Plant Health Inspection Service, Plant Protection and Quarantine,
Biotechnology and Scientific Services, Biotechnology Permits, 4700
River Road, Unit 147, Riverdale, Maryland 20737-1237. If there are
portions of the application deemed to contain trade secret or
confidential business information (CBI), each page of the application
containing such information should be marked ``CBI Copy''. In addition,
those portions of the application which are deemed ``CBI'' shall be so
designated. The second copy shall have all such CBI deleted and shall
be marked on each page of the application where CBI was deleted, ``CBI
Deleted''. If an application does not contain CBI then the first page
of both copies shall be marked ``No CBI''.
(b) Permit for release into the environment. An application for the
release into the environment of a regulated article shall be submitted
at least 120 days in advance of the proposed release into the
environment. An initial review shall be completed by APHIS within 30
days of the receipt of the application. If the application is complete,
the responsible individual shall be notified of the date of receipt of
the application for purposes of advising the applicant when the 120 day
review period commenced.\7\ If the application is not complete, the
responsible individual will be advised what additional information must
be submitted. APHIS shall commence the 120 day review period upon
receipt of the additional information, assuming the additional
information submitted is adequate. When it is determined that an
application is complete, APHIS shall submit to the State department of
agriculture of the State where the release is planned, a copy of the
initial review and a copy of the application marked, ``CBI Deleted'',
or ``No CBI'' for State notification and review. The application shall
include the following information: \8\
---------------------------------------------------------------------------
\7\ The 120 day review period would be extended if preparation
of an environmental impact statement in addition to an environmental
assessment was necessary.
\8\ Application forms are available without charge from the
Animal and Plant Health Inspection Service, Plant Protection and
Quarantine, Biotechnology and Scientific Services, Biotechnology
Permits, 4700 River Road, Unit 147, Riverdale, Maryland 20737-1237,
or from local offices which are listed in telephone directories. A
person should specify in requesting the application that the permit
is for the introduction of a regulated article subject to regulation
under part 340.
---------------------------------------------------------------------------
(1) Name, title, address, telephone number, signature of the
responsible person and type of permit requested (for importation,
interstate movement, or release into the environment);
(2) All scientific, common, and trade names, and all designations
necessary to identify the: Donor organism(s); recipient organism(s);
vector or vector agent(s); constituent of each regulated article which
is a product; and, regulated article;
(3) Names, addresses, and telephone numbers of the persons who
developed and/or supplied the regulated article;
(4) A description of the means of movement (e.g., mail, common
carrier, baggage, or handcarried (and by whom));
(5) A description of the anticipated or actual expression of the
altered genetic material in the regulated article and how that
expression differs from the expression in the non-modified parental
organism (e.g., morphological or structural characteristics,
physiological activities and processes, number of copies of inserted
genetic material and the physical state of this material inside the
recipient organism (integrated or extrachromosomal), products and
secretions, growth characteristics);
(6) A detailed description of the molecular biology of the system
(e.g., donor-recipient-vector) which is or will be used to produce the
regulated article;
(7) Country and locality where the donor organism, recipient
organism, vector or vector agent, and regulated article were collected,
developed, and produced;
(8) A detailed description of the purpose for the introduction of
the regulated article including a detailed description of the proposed
experimental and/or production design;
(9) The quantity of the regulated article to be introduced and
proposed schedule and number of introductions;
(10) A detailed description of the processes, procedures, and
safeguards which have been used or will be used in the country of
origin and in the United States to prevent contamination, release, and
dissemination in the production of the: Donor organism; recipient
organism; vector or vector agent; constituent of each regulated article
which is a product; and regulated article;
(11) A detailed description of the intended destination (including
final and all intermediate destinations), uses, and/or distribution of
the regulated article (e.g., greenhouses, laboratory, or growth chamber
location; field trial location; pilot project location; production,
propagation, and manufacture location; proposed sale and distribution
location);
(12) A detailed description of the proposed procedures, processes,
and safeguards which will be used to prevent escape and dissemination
of the regulated article at each of the intended destinations;
(13) A detailed description of any biological material (e.g.,
culture medium, or host material) accompanying the regulated article
during movement; and
(14) A detailed description of the proposed method of final
disposition of the regulated article.
(c) Limited permits for interstate movement or importation of a
regulated article. An application for the interstate movement or
importation of a regulated article shall be submitted at least 60 days
in advance of the first proposed interstate movement and at least 60
days prior to each importation. An initial review shall be completed by
APHIS within 15 days of the receipt of the application. If the
application is complete, the responsible person shall be notified of
the date of receipt of the application for purposes of advising the
applicant when the 60 day review period commenced. If the application
is not complete, the responsible person will be advised what additional
information must be submitted. APHIS shall commence the 60 day review
period upon receipt of the additional information, assuming the
additional information submitted is adequate. When it is determined
that an application is complete, APHIS shall submit to the State
department of agriculture of the State of destination of the regulated
article a copy of the initial review and the application marked, ``CBI
Deleted'', or ``No CBI'' for State notification and review.
(1) Limited permit for interstate movement. The responsible person
may apply for a single limited permit for the interstate movement of
multiple regulated articles in lieu of submitting an application for
each individual
[[Page 25130]]
interstate movement. Each limited permit issued shall be numbered and
shall be valid for one year from the date of issuance. If a permit is
sought for multiple interstate movements between contained facilities
the responsible individual shall specify in the permit application all
the regulated articles to be moved interstate; the origins and
destinations of all proposed shipments; a detailed description of all
the contained facilities where regulated articles will be utilized at
destination; and a description of the containers that will be used to
transport the regulated articles. A limited permit for interstate
movement of a regulated article shall only be valid for the movement of
those regulated articles moving between those locations specified in
the application. If a person seeks to move regulated articles other
than those specified in the application, or to a location other than
those listed in the application, a supplemental application shall be
submitted to APHIS. No person shall move a regulated article interstate
unless the number of the limited permit appears on the outside of the
shipping container. The responsible person shipping a regulated article
interstate shall keep records for one year demonstrating that the
regulated article arrived at its intended destination. The responsible
person seeking a limited permit for interstate movement shall submit on
an application form obtained from APHIS, the data required by
paragraphs (b)(1), (2), (4), (6), (7), (9), and (11) through (14) of
this section.
(2) Limited permit for importation. The responsible person seeking
a permit for the importation of a regulated article shall submit an
application for a permit prior to the importation of each shipment of
regulated articles. The responsible person importing a regulated
article shall keep records for one year demonstrating that the
regulated article arrived at its intended destination. The responsible
person seeking a limited permit for importation shall submit on an
application form obtained from APHIS data required by paragraphs
(b)(1), (2), (4), (6), (7), (9), and (11) through (14) of this
section.\9\
---------------------------------------------------------------------------
\9\ Renewals may receive shorter review. In the case of a
renewal for a limited permit for importation that has been issued
less than one year earlier, APHIS will notify the responsible person
within 15 days that either: (1) The renewal permit is approved or
(2) that a 60 day review period is necessary because the conditions
of the original permit have changed.
---------------------------------------------------------------------------
(d) Premises inspection. An inspector may inspect the site or
facility where regulated articles are proposed, pursuant to a permit,
to be released into the environment or contained after their interstate
movement or importation. Failure to allow the inspection of a premises
prior to the issuance of a permit or limited permit shall be grounds
for the denial of the permit.
(e) Administrative action on applications. After receipt and review
by APHIS of the application and the data submitted pursuant to
paragraph (a) of this section, including any additional information
requested by APHIS, a permit shall be granted or denied. If a permit is
denied, the applicant shall be promptly informed of the reasons why the
permit was denied and given the opportunity to appeal the denial in
accordance with the provisions of paragraph (g) of this section. If a
permit is granted, the permit will specify the applicable conditions
for introduction of the regulated article under this part.
(f) Permit conditions. A person who is issued a permit and his/her
employees or agents shall comply with the following conditions, and any
supplemental conditions which shall be listed on the permit, as deemed
by the Administrator to be necessary to prevent the dissemination and
establishment of plant pests:
(1) The regulated article shall be maintained and disposed of (when
necessary) in a manner so as to prevent the dissemination and
establishment of plant pests.
(2) All packing material, shipping containers, and any other
material accompanying the regulated article shall be treated or
disposed of in such a manner so as to prevent the dissemination and
establishment of plant pests.
(3) The regulated article shall be kept separate from other
organisms, except as specifically allowed in the permit;
(4) The regulated article shall be maintained only in areas and
premises specified in the permit;
(5) An inspector shall be allowed access, during regular business
hours, to the place where the regulated article is located and to any
records relating to the introduction of a regulated article;
(6) The regulated article shall, when possible, be kept identified
with a label showing the name of the regulated article, and the date of
importation;
(7) The regulated article shall be subject to the application of
measures determined by the Administrator to be necessary to prevent the
accidental or unauthorized release of the regulated article;
(8) The regulated article shall be subject to the application of
remedial measures (including disposal) determined by the Administrator
to be necessary to prevent the spread of plant pests;
(9) A person who has been issued a permit shall submit to APHIS a
field test report within 6 months after the termination of the field
test. A field test report shall include the APHIS reference number,
methods of observation, resulting data, and analysis regarding all
deleterious effects on plants, nontarget organisms, or the environment.
(10) APHIS shall be notified within the time periods and manner
specified below, in the event of the following occurrences:
(i) Orally notified immediately upon discovery and notify in
writing within 24 hours in the event of any accidental or unauthorized
release of the regulated article;
(ii) In writing as soon as possible but not later than within 5
working days if the regulated article or associated host organism is
found to have characteristics substantially different from those listed
in the application for a permit or suffers any unusual occurrence
(excessive mortality or morbidity, or unanticipated effect on non-
target organisms);
(11) A permittee or his/her agent and any person who seeks to
import a regulated article into the United States shall:
(i) Import or offer the regulated article for entry only through
any USDA plant inspection station listed in accordance with Sec.
319.37-8(a) of this chapter;
(ii) Notify APHIS promptly upon arrival of any regulated article at
a port of entry, of its arrival by such means as a manifest, customs
entry document, commercial invoice, waybill, a broker's document, or a
notice form provided for such purpose; and
(iii) Mark and identify the regulated article in accordance with
Sec. 340.5 of this part.
(g) Withdrawal or denial of a permit. Any permit which has been
issued may be withdrawn by an inspector or the Administrator if he/she
determines that the holder thereof has not complied with one or more of
the conditions listed on the permit. APHIS will confirm the reasons for
the withdrawal of the permit in writing within ten (10) days. Any
person whose permit has been withdrawn or any person who has been
denied a permit may appeal the decision in writing to the Administrator
within ten (10) days after receiving the written notification of the
withdrawal or denial. The appeal shall state all of the facts and
reasons upon which the person relies to show that the permit was
wrongfully withdrawn or denied. The Administrator shall grant or deny
the appeal, in writing, stating the
[[Page 25131]]
reasons for the decision as promptly as circumstances allow. If there
is a conflict as to any material fact, a hearing shall be held to
resolve such conflict. Rules of practice concerning such a hearing will
be adopted by the Administrator.
(h) Courtesy permit--(1) Issuance. The Administrator may issue a
courtesy permit for the introduction of organisms modified through
genetic engineering which are not subject to regulation under this part
to facilitate movement when the movement might otherwise be impeded
because of the similarity of the organism to other organisms regulated
under this part.
(2) Application. A person seeking a courtesy permit shall submit on
an application form obtained from APHIS data required by paragraphs
(b)(1), (2), and (5) of this section and shall indicate such data is
being submitted as a request for a courtesy permit. A person should
also include a statement explaining why he or she believes the organism
or product does not come within the definition of a regulated article.
The application shall be submitted at least 60 days prior to the time
the courtesy permit is sought.
(3) Administrative action. APHIS shall complete an initial review
within 15 days of the date of receipt of the application. If the
application is complete, the responsible individual shall be notified
of the date of receipt of the application for purposes of advising the
applicant when the 60 day review period commenced. If the application
is not complete, the responsible individual will be advised what
additional information must be submitted, and shall commence the 60 day
review period upon receipt of the additional information, assuming the
additional information submitted is adequate. Within 60 days from the
date of receipt of a complete application, APHIS will either issue a
courtesy permit or advise the responsible individual that a permit is
required under paragraph (b) or (c) of this section.
(Approved by the Office of Management and Budget under control number
0579-0216)
Sec. 340.5 Petition to amend the list of organisms.10
---------------------------------------------------------------------------
\10\ See footnote 5 in Sec. 340.3.
---------------------------------------------------------------------------
(a) General. Any person may submit to the Administrator a petition
to amend the list of organisms in Sec. 340.2 of this part by adding or
deleting any genus, species, or subspecies. A petitioner may
supplement, amend, or withdraw a petition in writing without prior
approval of the Administrator and without prejudice to resubmission at
any time until the Administrator rules on the petition. A petition to
amend the list of organisms shall be submitted in accordance with the
procedures and format specified by this section.
(b) Submission procedures and format. A person shall submit two
copies of a petition to the Animal and Plant Health Inspection Service,
Biotechnology and Scientific Services, PPQ, Biotechnology Permits, 4700
River Road, Unit 147, Riverdale, Maryland 20737-1237. The petition
should be dated, and structured as follows:
Petition To Amend 7 CFR 340.2
The undersigned submits this petition under 7 CFR 340.4 to request
that the Administrator [add the following genus, species, or subspecies
to the list of organisms in 7 CFR 340.2] or [to remove the following
genus, species, or subspecies from the list of organisms in Sec.
340.2].
A. Statement of Grounds
(A person must present a full statement explaining the factual
grounds why the genus, species, or subspecies to be added to Sec.
340.2 of this part is a plant pest or why there is reason to believe
the genus, species, or subspecies is a plant pest or why the genus,
species, or subspecies sought to be removed is not a plant pest or why
there is reason to believe the genus, species, or subspecies is not a
plant pest. The petition should include copies of scientific literature
which the petitioner is relying upon, copies of unpublished studies, or
data from tests performed. The petition should not include trade secret
or confidential business information.
A person should also include representative information known to
the petitioner which would be unfavorable to a petition for listing or
delisting. (If a person is not aware of any unfavorable information the
petition should state, Unfavorable Information: NONE).
B. Certification
The undersigned certifies, that to the best knowledge and belief of
the undersigned, this petition includes all information and views on
which the petitioner relies, and that it includes representative data
and information known to the petitioner which are unfavorable to the
petition.
(Signature) ____________
(Name of petitioner) ________
(Mailing address) _________
(Telephone number) ________
(c) Administrative action on a petition. (1) A petition to amend
the list of organisms which meets the requirements of paragraph (b) of
this section will be filed by the APHIS, stamped with the date of
filing, and assigned a docket number. The docket number shall identify
the file established for all submissions relating to the petition.
APHIS, will promptly notify the petitioner in writing of the filing and
docket number of a petition. If a petition does not meet the
requirements of paragraph (b) of this section, the petitioner shall be
sent a notice indicating how the petition is deficient.
(2) After the filing of a petition to amend the list of organisms
USDA shall publish a proposal in the Federal Register to amend Sec.
340.2 and solicit comments thereon from the public. An interested
person may submit written comments to the APHIS on a filed petition,
which shall become part of the docket file.
(3) The Administrator shall furnish a response to each petitioner
within 180 days of receipt of the petition. The response will either:
(i) Approve the petition in whole or in part in which case the
Administrator shall concurrently take appropriate action (publication
of a document in the Federal Register amending Sec. 340.2 of this
part); or
(ii) deny the petition in whole or in part. The petitioner shall be
notified in writing of the Administrator's decision. The decision shall
be placed in the public docket file in the offices of APHIS, and in the
form of a notice published in the Federal Register.
Sec. 340.6 Petition for determination of nonregulated status.\11\
---------------------------------------------------------------------------
\11\ See footnote 5 in Sec. 340.3.
---------------------------------------------------------------------------
(a) General. Any person may submit to the Administrator, a petition
to seek a determination that an article should not be regulated under
this part. A petitioner may supplement, amend, or withdraw a petition
in writing without prior approval of the Administrator, and without
affecting resubmission at any time until the Administrator, rules on
the petition. A petition for determination of nonregulated status shall
be submitted in accordance with the procedure and format specified in
this section.
(b) Submission procedures and format. A person shall submit two
copies of a petition to the Animal and Plant Health Inspection Service,
Plant Protection and Quarantine, Biotechnology and Scientific Services,
Biotechnology Coordination and Technical Assistance, 4700 River Road,
Unit 146, Riverdale, Maryland 20737-
[[Page 25132]]
1237. The petition shall be dated and structured as follows:
Petition for Determination of Nonregulated Status
The undersigned submits this petition under 7 CFR 340.6 to request
that the Administrator, make a determination that the article should
not be regulated under 7 CFR part 340.
Signature _____________
A. Statement of Grounds
A person must present a full statement explaining the factual
grounds why the organism should not be regulated under 7 CFR part 340.
The petitioner shall include copies of scientific literature, copies of
unpublished studies, when available, and data from tests performed upon
which to base a determination. The petition shall include all
information set forth in paragraph (c) of 7 CFR 340.6. If there are
portions of the petition deemed to contain trade secret or confidential
business information (CBI), each page of the petition containing such
information should be marked ``CBI Copy''. In addition, those portions
of the petition which are deemed ``CBI'' shall be so designated. The
second copy shall have all such CBI deleted and shall have marked on
each page where the CBI was deleted: ``CBI Deleted.'' If a petition
does not contain CBI, the first page of both copies shall be marked:
``No CBI.''
A person shall also include information known to the petitioner
which would be unfavorable to a petition. If a person is not aware of
any unfavorable information, the petition should state, ``Unfavorable
information: NONE.''
B. Certification
The undersigned certifies, that to the best knowledge and belief of
the undersigned, this petition includes all information and views on
which to base a determination, and that it includes relevant data and
information known to the petitioner which are unfavorable to the
petition.
(Signature) ____________
(Name of petitioner) ________
(Mailing address) _________
(Telephone number) ________
(c) Required data and information. The petition shall include the
following information:
(1) Description of the biology of the nonmodified recipient plant
and information necessary to identify the recipient plant in the
narrowest taxonomic grouping applicable.
(2) Relevant experimental data and publications.
(3) A detailed description of the differences in genotype between
the regulated article and the nonmodified recipient organism. Include
all scientific, common, or trade names, and all designations necessary
to identify: the donor organism(s), the nature of the transformation
system (vector or vector agent(s)), the inserted genetic material and
its product(s), and the regulated article. Include country and locality
where the donor, the recipient, and the vector organisms and the
regulated articles are collected, developed, and produced.
(4) A detailed description of the phenotype of the regulated
article. Describe known and potential differences from the unmodified
recipient organism that would substantiate that the regulated article
is unlikely to pose a greater plant pest risk than the unmodified
organism from which it was derived, including but not limited to: Plant
pest risk characteristics, disease and pest susceptibilities,
expression of the gene product, new enzymes, or changes to plant
metabolism, weediness of the regulated article, impact on the weediness
of any other plant with which it can interbreed, agricultural or
cultivation practices, effects of the regulated article on nontarget
organisms, indirect plant pest effects on other agricultural products,
transfer of genetic information to organisms with which it cannot
interbreed, and any other information which the Administrator believes
to be relevant to a determination. Any information known to the
petitioner that indicates that a regulated article may pose a greater
plant pest risk than the unmodified recipient organism shall also be
included.
(5) Field test reports for all trials conducted under permit or
notification procedures, involving the regulated article, that were
submitted prior to submission of a petition for determination of
nonregulated status or prior to submission of a request for extension
of a determination of nonregulated status under paragraph (e) of this
part. Field test reports shall include the APHIS reference number,
methods of observation, resulting data, and analysis regarding all
deleterious effects on plants, nontarget organisms, or the environment.
(d) Administrative action on a petition. (1) A petition for
determination of nonregulated status under this part which meets the
requirements of paragraphs (b) and (c) of this section will be filed by
the Administrator, stamped with the date of filing, and assigned a
petition number. The petition number shall identify the file
established for all submissions relating to the petition. APHIS will
promptly notify the petitioner in writing of the filing and the
assigned petition number. If a petition does not meet the requirements
specified in this section, the petitioner shall be sent a notice
indicating how the petition is deficient.
(2) After the filing of a completed petition, APHIS shall publish a
notice in the Federal Register. This notice shall specify that comments
will be accepted from the public on the filed petition during a 60 day
period commencing with the date of the notice. During the comment
period, any interested person may submit to the Administrator, written
comments, regarding the filed petition, which shall become part of the
petition file.
(3) The Administrator shall, based upon available information,
furnish a response to each petitioner within 180 days of receipt of a
completed petition. The response will either:
(i) Approve the petition in whole or in part; or
(ii) deny the petition.
The petitioner shall be notified in writing of the Administrator's
decision. The decision shall be placed in the public petition file in
the offices of APHIS and notice of availability published in the
Federal Register.
(e) Extensions to determinations of nonregulated status. (1) The
Administrator may determine that a regulated article does not pose a
potential for plant pest risk, and should therefore not be regulated
under this part, based on the similarity of that organism to an
antecedent organism.
(2) A person may request that APHIS extend a determination of
nonregulated status to other organisms. Such a request shall include
information to establish the similarity of the antecedent organism and
the regulated articles in question.
(3) APHIS will announce in the Federal Register all preliminary
decisions to extend determinations of nonregulated status 30 days
before the decisions become final and effective. If additional
information becomes available that APHIS believes justifies changing
its decision, it will issue a revised decision.
(4) If a request to APHIS to extend a determination of nonregulated
status under this part is denied, APHIS will inform the submitter of
that request of the reasons for denial. The submitter may submit a
modified request or a separate petition for determination of
nonregulated status without prejudice.
[[Page 25133]]
(f) Denial of a petition; appeal. (1) The Administrator's written
notification of denial of a petition shall briefly set forth the reason
for such denial. The written notification shall be sent by certified
mail. Any person whose petition has been denied may appeal the
determination in writing to the Administrator within 10 days from
receipt of the written notification of denial.
(2) The appeal shall state all of the facts and reasons upon which
the person relies, including any new information, to show that the
petition was wrongfully denied. The Administrator shall grant or deny
the appeal, in writing, stating the reasons for the decision as
promptly as circumstances allow. An informal hearing may be held by the
Administrator if there is a dispute of a material fact. Rules of
Practice concerning such a hearing will be adopted by the
Administrator.
Sec. 340.7 Marking and identity.
(a) Any regulated article to be imported other than by mail, shall,
at the time of importation into the United States, plainly and
correctly bear on the outer container the following information:
(1) General nature and quantity of the contents;
(2) Country and locality where collected, developed, manufactured,
reared, cultivated or cultured;
(3) Name and address of shipper, owner, or person shipping or
forwarding the organism;
(4) Name, address, and telephone number of consignee;
(5) Identifying shipper's mark and number; and
(6) Number of written permit authorizing the importation.
(b) Any regulated article imported by mail, shall be plainly and
correctly addressed and mailed to APHIS through any USDA plant
inspection station listed in accordance with Sec. 319.37-8(a) of this
chapter and shall be accompanied by a separate sheet of paper within
the package plainly and correctly bearing the name, address, and
telephone number of the intended recipient, and shall plainly and
correctly bear on the outer container the following information:
(1) General nature and quantity of the contents;
(2) Country and locality where collected, developed, manufactured,
reared, cultivated, or cured;
(3) Name and address of shipper, owner, or person shipping or
forwarding the regulated article; and
(4) Number of permit authorizing the importation.
(c) Any regulated article imported into the United States by mail
or otherwise shall, at the time of importation or offer for importation
into the United States, be accompanied by an invoice or packing list
indicating the contents of the shipment.
Sec. 340.8 Container requirements for the movement of regulated
articles.
(a) General requirements. A regulated article shall not be moved
unless it complies with the provisions of paragraph (b) of this
section, unless a variance has been granted in accordance with the
provisions of paragraph (c) of this section.\12\
---------------------------------------------------------------------------
\12\ The requirements of this section are in addition to and not
in lieu of any other packing requirements such as those for the
transportation of etiologic agents prescribed by the Department of
Transportation in Title 49 CFR or any other agency of the Federal
government.
---------------------------------------------------------------------------
(b) Container requirements--(1) Plants and plant parts. All plants
or plant parts, except seeds, cells, and subcellular elements, shall be
packed in a sealed plastic bag of at least 5 mil thickness, inside a
sturdy, sealed, leak-proof, outer shipping container constructed of
corrugated fiberboard, corrogated cardboard, wood, or other material of
equivalent strength.
(2) Seeds. All seeds shall be transported in a sealed plastic bag
of at least 5 mil thickness, inside a sealed metal container, which
shall be placed inside a second sealed metal container. Shock absorbing
cushioning material shall be placed between the inner and outer metal
containers. Each metal container shall be independently capable of
protecting the seeds and preventing spillage or escape. Each set of
metal containers shall then be enclosed in a sturdy outer shipping
container constructed of corrugated fiberboard, corrugated cardboard,
wood, or other material of equivalent strength.
(3) Live microorganisms and/or etiologic agents, cells, or
subcellular elements. All regulated articles which are live (non-
inactivated) microorganisms, or etiologic agents, cells, or subcellular
elements shall be packed as specified below:
(i) Volume not exceeding 50 ml. Regulated articles not exceeding 50
ml shall be placed in a securely closed, watertight container (primary
container, test tube, vial, etc.) which shall be enclosed in a second,
durable watertight container (secondary container). Several primary
containers may be enclosed in a single secondary container, if the
total volume of all the primary containers so enclosed does not exceed
50 ml. The space at the top, bottom, and sides between the primary and
secondary containers shall contain sufficient nonparticulate absorbent
material (e.g., paper towel) to absorb the entire contents of the
primary container(s) in case of breakage or leakage. Each set of
primary and secondary containers shall then be enclosed in an outer
shipping container constructed of corrugated fiberboard, corrugated
cardboard, wood, or other material of equivalent strength.
(ii) Volume greater than 50 ml. Regulated articles which exceed a
volume of 50 ml. shall comply with requirements specified in paragraph
(b)(3)(i) of this section. In addition, a shock absorbing material, in
volume at least equal to that of the absorbent material between the
primary and secondary containers, shall be placed at the top, bottom,
and sides between the secondary container and the outer shipping
container. Single primary containers shall not contain more than 1,000
ml. of material. However, two or more primary containers whose combined
volumes do not exceed 1,000 ml. may be placed in a single, secondary
container. The maximum amount of micro-organisms or etiologic agents,
cells, or subcellular elements which may be enclosed within a single
outer shipping container shall not exceed 4,000 ml.
(iii) Dry ice. If dry ice is used as a refrigerant, it shall be
placed outside the secondary container(s). If dry ice is used between
the secondary container and the outer shipping container, the shock
absorbing material shall be placed so that the secondary container does
not become loose inside the outer shipping container as the dry ice
sublimates.
(4) Insects, mites, and related organisms. Insects, mites, and
other small arthropods shall be packed for shipment as specified in
this paragraph or in paragraph (b)(3) of this section. Insects (any
life stage) shall be placed in an escape-proof primary shipping
container (insulated vacuum container, glass, metal, plastic, etc.) and
sealed to prevent escape. Such primary container shall be placed
securely within a secondary shipping container of crushproof styrofoam
or other material of equivalent strength; one or more rigid ice packs
may also be placed within the secondary shipping container; and
sufficient packing material shall be added around the primary container
to prevent movement of the primary shipping container. The secondary
(styrofoam or other) container shall be placed securely within an outer
shipping container constructed of corrugated fiberboard, corrugated
cardboard, wood, or other material of equivalent strength.
[[Page 25134]]
(5) Other macroscopic organisms. Other macroscopic organisms not
covered in paragraphs (b)(1), (2), and (4) of this section which do not
require continuous access to atmospheric oxygen shall be packaged as
specified in paragraph (b)(3) or (b)(4) of this section. All
macroscopic organisms which are not plants and which require continuous
access to atmospheric oxygen shall be placed in primary shipping
containers constructed of a sturdy, crush-proof frame of wood, metal,
or equivalent strength material, surrounded by escape-proof mesh or
netting of a strength and mesh size sufficient to prevent the escape of
the smallest organism in the shipment, with edges and seams of the mesh
or netting sealed to prevent escape of organisms. Each primary shipping
container shall be securely placed within a larger secondary shipping
container constructed of wood, metal, or equivalent strength material.
The primary and secondary shipping containers shall then be placed
securely within an outer shipping container constructed of corrugated
fiberboard, corrugated cardboard, wood, or other material of equivalent
strength, which outer container may have air holes or spaces in the
sides and/or ends of the container, provided that the outer shipping
container must retain sufficient strength to prevent crushing of the
primary and secondary shipping containers.
(c) Request for a variance from container requirements. A
responsible person who believes the container requirements normally
applicable to the movement of the person's regulated article(s) are
inappropriate due to unique circumstances (such as the nature, volume,
or life stage of the regulated article) may submit in an application
for a permit, a request for a variance from the container requirements.
The request for a variance under this section shall consist of a short
statement describing why the normally applicable container requirements
are inappropriate for the regulated article which the person proposes
to move and what container requirements the person would use in lieu of
the normally prescribed container requirements. USDA shall advise the
responsible person in writing at the time a permit is granted on the
person's request for a variance.
Sec. 340.9 Costs and charges.
The services of the inspector during regularly assigned hours of
duty and at the usual places of duty shall be furnished without
cost.\13\ The U.S. Department of Agriculture will not be responsible
for any costs or charges incident to inspections or compliance with the
provisions of this part, other than for the services of the inspector.
---------------------------------------------------------------------------
\13\ The Department's provisions relating to overtime charges
for an inspector's services are set forth in 7 CFR part 354.
---------------------------------------------------------------------------
PART 372--NATIONAL ENVIRONMENTAL POLICY ACT IMPLEMENTING PROCEDURES
0
4. The authority citation for part 372 continues to read as follows:
Authority: 42 U.S.C. 4321 et seq.; 40 CFR 1500-1508; 7 CFR 1b,
2.22, 2.80, and 371.9.
0
5. Amend Sec. 372.5 as follows:
0
a. By adding paragraph (b)(7);
0
b. In paragraph (c)(3)(iii), by removing ``for'' and adding ``, or
acknowledgment of notifications for,'' in its place; and
0
c. By adding paragraph (c)(4).
The additions read as follows:
Sec. 372.5 Classification of actions.
* * * * *
(b) * * *
(7) Determination of nonregulated status for genetically engineered
organisms.
(c) * * *
(4) Extending deregulations for genetically engineered organisms.
Extension of nonregulated status under part 340 of this chapter to
organisms similar to those already deregulated.
* * * * *
Done in Washington, DC, this 9th day of June 2025.
Michael Watson,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2025-10797 Filed 6-13-25; 8:45 am]
BILLING CODE 3410-34-P